Using CT scans to prevent heart attacks
Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (The SCOT-HEART 2 Trial)
This study tests if using CT scans can help middle-aged people at risk for heart disease avoid heart attacks better than the usual methods based on risk scores.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6000 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 1 site (Edinburgh, City Of Edinburgh) |
| Trial ID | NCT03920176 on ClinicalTrials.gov |
What this trial studies
This trial investigates whether computed tomography coronary angiography (CTCA) can more effectively guide management and reduce the risk of heart attacks compared to traditional cardiovascular risk scores in middle-aged individuals at risk for cardiovascular disease. The study will involve at least 6,000 participants aged 40 to 70 who have specific risk factors for heart disease. Participants will be randomly assigned to receive either CTCA-guided management or standard care based on risk scores, with the aim of determining which approach leads to better outcomes in preventing coronary heart disease events.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 to 70 residing in Scotland with specific cardiovascular risk factors.
Not a fit: Patients with known coronary heart disease or those unable to undergo CTCA will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate targeting of preventative therapies and a reduction in heart attack rates.
How similar studies have performed: Previous studies have shown that CTCA can significantly change the management of patients with stable chest pain and reduce future heart events, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA * ≥40 and ≤70 years of age * Resident in Scotland and have a Community Health Index (CHI) number * One or more of the following risk factors: * \>60 years of age * Current or recent (within 12 months) smoker * Clinical diagnosis of hypertension * Known hypercholesterolaemia or total cholesterol \>6.0 mmol/L or receiving statin therapy * Diabetes mellitus * Rheumatoid arthritis * Systemic lupus erythematosus (SLE) * Family history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease below 60 years) * Chronic kidney disease stage 3 (estimate glomerular filtration rate 30-59 mL/min/1.73 m2). EXCLUSION CRITERIA * Inability to undergo CTCA * Known coronary heart disease or other major atherosclerotic cardiovascular disease * Prior invasive or non-invasive coronary angiography within the last 5 years * Chronic kidney disease stage ≥4 (estimate glomerular filtration rate \<30 mL/min/1.73 m2) * Known homozygous familial hypercholesterolaemia or other serious inherited disorders of lipid metabolism requiring statin therapy * Intolerance of all statins * Statin therapy for \>2 years. * Previous coronary artery imaging completed specifically for cardiovascular risk assessment with a result of \>10 AU.
Where this trial is running
Edinburgh, City Of Edinburgh
- Western General Hospital — Edinburgh, City Of Edinburgh, United Kingdom (Recruiting)
Study contacts
- Principal investigator: David E Newby — University of Edinburgh
- Study coordinator: David E Newby
- Email: d.e.newby@ed.ac.uk
- Phone: 01312426515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.